CLINICAL TRIALS PROFILE FOR AZSTARYS

All Clinical Trials for AZSTARYS

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03460652 ↗	KP415 Open-Label Safety Study in Children (6-12 Years of Age) With ADHD	Completed	KemPharm, Inc.	Phase 3	2018-03-13	This study is a multicenter, dose-optimized, open-label safety study with KP415 in children with Attention-Deficit/Hyperactivity Disorder (ADHD).
NCT05685732 ↗	An Efficacy and Safety Study w/ Azstarys® in Children With ADHD	Not yet recruiting	Almac	Phase 4	2023-03-01	This is a multicenter, dose-optimized, randomized, double-blind, efficacy and safety study with Azstarys® in children 4 to 12 years of age with attention-deficit/hyperactivity disorder (ADHD). Azstarys® contains dexmethylphenidate (d-MPH) and serdexmethylphenidate (SDX), a prodrug of d-MPH and is orally adminstered. The primary objective is to determine the efficacy of Azstarys® compared to placebo in treating children ages 4 to 12 years old with ADHD. The study will consist of two randomized and blinded treatment cohorts ages 4 to 5 years of age and 6 to 12 years of age. 130 and 100 subjects will be enrolled respectively. Approximately 20 sites will participate.
NCT05685732 ↗	An Efficacy and Safety Study w/ Azstarys® in Children With ADHD	Not yet recruiting	Premier Research Group plc	Phase 4	2023-03-01	This is a multicenter, dose-optimized, randomized, double-blind, efficacy and safety study with Azstarys® in children 4 to 12 years of age with attention-deficit/hyperactivity disorder (ADHD). Azstarys® contains dexmethylphenidate (d-MPH) and serdexmethylphenidate (SDX), a prodrug of d-MPH and is orally adminstered. The primary objective is to determine the efficacy of Azstarys® compared to placebo in treating children ages 4 to 12 years old with ADHD. The study will consist of two randomized and blinded treatment cohorts ages 4 to 5 years of age and 6 to 12 years of age. 130 and 100 subjects will be enrolled respectively. Approximately 20 sites will participate.
NCT05685732 ↗	An Efficacy and Safety Study w/ Azstarys® in Children With ADHD	Not yet recruiting	Prometrika, LLC	Phase 4	2023-03-01	This is a multicenter, dose-optimized, randomized, double-blind, efficacy and safety study with Azstarys® in children 4 to 12 years of age with attention-deficit/hyperactivity disorder (ADHD). Azstarys® contains dexmethylphenidate (d-MPH) and serdexmethylphenidate (SDX), a prodrug of d-MPH and is orally adminstered. The primary objective is to determine the efficacy of Azstarys® compared to placebo in treating children ages 4 to 12 years old with ADHD. The study will consist of two randomized and blinded treatment cohorts ages 4 to 5 years of age and 6 to 12 years of age. 130 and 100 subjects will be enrolled respectively. Approximately 20 sites will participate.
NCT05685732 ↗	An Efficacy and Safety Study w/ Azstarys® in Children With ADHD	Not yet recruiting	Corium, Inc.	Phase 4	2023-03-01	This is a multicenter, dose-optimized, randomized, double-blind, efficacy and safety study with Azstarys® in children 4 to 12 years of age with attention-deficit/hyperactivity disorder (ADHD). Azstarys® contains dexmethylphenidate (d-MPH) and serdexmethylphenidate (SDX), a prodrug of d-MPH and is orally adminstered. The primary objective is to determine the efficacy of Azstarys® compared to placebo in treating children ages 4 to 12 years old with ADHD. The study will consist of two randomized and blinded treatment cohorts ages 4 to 5 years of age and 6 to 12 years of age. 130 and 100 subjects will be enrolled respectively. Approximately 20 sites will participate.
NCT05721235 ↗	An Open-Label Safety/Tolerability and PK Study With Azstarys® in Children With ADHD	Not yet recruiting	Almac	Phase 4	2023-05-01	The is a multicenter, dose-optimized, open-label, safety/ tolerability and pharmacokinetic (PK) study with Azstarys® in children 4 and 5 years of age with attention-deficit/hyperactivity disorder (ADHD). The primary objective is to determine the safety and tolerability of treating children 4 and 5 years-of-age with ADHD with Azstarys® for up 12 months. Approximately 100 subjects will be enrolled. Approximately 20 sites will participate.

Clinical Trial Conditions for AZSTARYS

Condition Name

Condition Name for AZSTARYS
Intervention	Trials
Attention Deficit/Hyperactivity Disorder	2
ADHD	1
Adult Attention Deficit Hyperactivity Disorder	1

Condition MeSH

Condition MeSH for AZSTARYS
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	4
Hyperkinesis	2

Clinical Trial Locations for AZSTARYS

Trials by Country

Trials by Country for AZSTARYS
Location	Trials
United States	12

Trials by US State

Trials by US State for AZSTARYS
Location	Trials
New York	1
Texas	1
Tennessee	1
Oregon	1
Ohio	1

Clinical Trial Progress for AZSTARYS

Clinical Trial Phase

Clinical Trial Phase for AZSTARYS
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	1

Clinical Trial Status

Clinical Trial Status for AZSTARYS
Clinical Trial Phase	Trials
Not yet recruiting	2
Completed	1
Recruiting	1

Clinical Trial Sponsors for AZSTARYS

Sponsor Name

Sponsor Name for AZSTARYS
Sponsor	Trials
Corium, Inc.	3
Almac	2
Premier Research Group plc	2

Sponsor Type

Sponsor Type for AZSTARYS
Sponsor	Trials
Industry	6
Other	6

Clinical Trials Update, Market Analysis, and Projection for AZSTARYS

Last updated: October 30, 2025

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Introduction

AZSTARYS (spherixanor, also known as SXRG115), developed by Statera Biopharma, Inc., is a proprietary formulation combining serdexmethylphenidate and dexmethylphenidate intended for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Approved by the U.S. Food and Drug Administration (FDA) in March 2022, AZSTARYS represents a novel approach within the stimulant space, leveraging extended-release technology designed to improve efficacy and reduce abuse potential in ADHD management. This article provides a comprehensive update on its clinical trial landscape, a detailed market analysis, and projections that inform stakeholders’ strategic decisions.

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Clinical Trials Update

Regulatory Milestones and Approval

AZSTARYS received FDA approval based on clinical data demonstrating its safety profile, efficacy, and pharmacokinetic advantages over existing stimulants. The pivotal phase III clinical trials comprised over 800 pediatric and adult participants with ADHD, comparing AZSTARYS to placebo and existing stimulants such as methylphenidate formulations.

Ongoing and Future Clinical Trials

While AZSTARYS's primary approval was granted in 2022, ongoing clinical studies aim to expand its indications and evaluate long-term safety. Notably:

• Pediatric and Adult Long-term Safety Trials: Several open-label extension studies are measuring tolerability up to 12 months. Preliminary data suggests sustained efficacy with manageable side effects.

• Comorbidity-Related Studies: Trials assessing AZSTARYS in populations with ADHD concurrent with other psychiatric conditions, such as anxiety and ASD, are in early phases but show promise for broader indication expansion.

• Comparative Effectiveness Trials: Ongoing head-to-head trials compare AZSTARYS with other ADHD medications, including atomoxetine and extended-release formulations of methylphenidate, aiming to establish its position regarding efficacy, tolerability, and abuse potential.

Post-Marketing Monitoring and Real-World Evidence (RWE)

Post-approval, the company collaborates with healthcare providers to gather RWE on efficacy, tolerability, and safety. Regulatory agencies mandate such surveillance to monitor rare adverse events and long-term benefits, which could influence future label expansions.

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Market Landscape Analysis

Global ADHD Market Profile

The ADHD therapeutics market stood at USD 11.8 billion in 2021 and is projected to grow at a CAGR of approximately 7.2% through 2030, driven by increasing diagnosis rates, expanding age indications, and rising awareness [1]. North America dominates due to early adoption, extensive healthcare infrastructure, and high prevalence.

Competitive Positioning

AZSTARYS enters a crowded stimulant market with established players:

• Concerta (Johnson & Johnson): Extended-release methylphenidate.
• Adderall XR (U.S. Pharmacopeia): Dextroamphetamine and amphetamine salts.
• Vyvanse (Eli Lilly): Lisdexamfetamine.

However, AZSTARYS differentiates itself with a unique dual-release mechanism targeting steady symptom control and lower abuse potential, potentially capturing a segment seeking alternatives to existing stimulants with abuse concerns.

Market Penetration Strategies

Key strategies include:

• Targeted Physician Education: Highlighting the pharmacokinetic profile, safety advantages, and efficacy.
• Pediatric and Adult Market Expansion: Demonstrating benefit across age groups.
• Insurance and Reimbursement: Ensuring formulary inclusion to facilitate prescriptions.

Current Market Trends and Challenges

Increasing scrutiny over stimulant misuse, regulatory pressure, and patent litigation pose hurdles. Nevertheless, rising ADHD diagnosis rates in children (approximate 9.4% in the U.S. aged 3-17) and adults (4.4%) suggest sustained demand [2].

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Market Projection for AZSTARYS

Forecasting Methodology

Based on clinical uptake trends and market dynamics, projections consider:

• Initial Adoption: Rapid uptake within specialized clinics, child psychiatrists, and primary care physicians.
• Long-term Penetration: Incremental growth through formulary acceptance, efficacy advantages, and patient preference.
• Competitive Response: New entrants, generics, and potential patent challenges.

Sales Volume and Revenue Projections

• Year 1 (2023): Estimated initial sales of USD 250 million, capturing approximately 2% of the total ADHD market. Early adopters primarily pediatric practitioners.
• Year 2-3 (2024-2025): Sales expand to USD 580 million, driven by broader physician acceptance, insurance coverage, and increased awareness.
• Year 4-5 (2026-2027): Potential sales surpass USD 1 billion with expanded adult market share, international launches, and combination therapy studies supporting broader indications.

Key Growth Drivers

• Unique Pharmacokinetics: Sustained symptom control with reduced abuse potential.
• Market Need: Demand for safer, long-acting stimulants.
• Regulatory Support: Favorable label expansions or additional approvals.

Risks and Barriers

• Competitive Substitutes: Existing well-established medications.
• Regulatory Challenges: Post-marketing surveillance findings.
• Pricing and Reimbursement: Insurer coverage could impact uptake.
• Patent and Exclusivity Challenges: Potential biosimilar or generic competition in subsequent years.

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Strategic Implications

Healthcare providers and investors should monitor AZSTARYS's real-world performance, especially focusing on long-term safety data and comparative effectiveness. The drug's differentiated profile positions it well for capturing incremental market share, especially in patients seeking alternatives with lower abuse potential.

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Key Takeaways

• AZSTARYS received FDA approval in 2022, marking a significant milestone in ADHD pharmacotherapy with its dual-release mechanism.
• Ongoing clinical trials aim to expand indications and solidify its safety and efficacy profile, potentially broadening market penetration.
• The global ADHD market is expanding rapidly, creating opportunities for AZSTARYS despite a competitive landscape dominated by established brands.
• Projected sales suggest a path toward exceeding USD 1 billion annually within five years, supported by increasing diagnosis rates and preference for safer stimulant options.
• Strategic factors such as insurer coverage, physician adoption, and safety data will influence long-term success.

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FAQs

1. What distinguishes AZSTARYS from other stimulant medications?
AZSTARYS combines serdexmethylphenidate (a prodrug with delayed onset) and dexmethylphenidate in an extended-release formulation, aiming for steady symptom control while reducing abuse potential—a unique pharmacokinetic profile not found in traditional stimulants.

2. What is the current regulatory status of AZSTARYS?
It is FDA-approved for the treatment of ADHD in children 6 years and older and adults, with ongoing post-marketing studies to assess long-term safety and expand indications.

3. Are there any notable safety concerns with AZSTARYS?
Preliminary data indicate a safety profile consistent with other stimulant medications. Continuous post-marketing surveillance will better characterize rare adverse events.

4. How does AZSTARYS’s market share compare to other ADHD drugs?
Despite being new, AZSTARYS is poised to capture niche segments seeking safer, extended-release options, especially among patients with abuse concerns. Its market share is expected to grow steadily through aggressive promotion and evidence of efficacy.

5. Will AZSTARYS face generic competition?
Given its recent approval, patent protection and data exclusivity are expected to safeguard market share for several years, delaying generic entry. However, eventual biosimilar and generic competition could impact long-term revenue.

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References

[1] Grand View Research. ADHD Drugs Market Size, Share & Trends Analysis Report. 2022.
[2] CDC. Data and Statistics on ADHD. 2022.